FDA advisors oppose Pfizer’s Talzenna expansion bid

Today’s Big News

May 22, 2025

GSK revs up launch plans after Nucala's FDA approval in COPD, targeting £500M opportunity


Sanofi inks $470M Vigil buyout, brushing off rivals' failures to join Novartis in Alzheimer's race


FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population


With Illumina sequencers under an import ban, PacBio expands its footprint in China


Gilead pays partner Hookipa $10M to take over HBV, HIV therapeutic vaccine programs


Novo offers Wegovy discount for new patients, launches new ad campaign as time runs out for compounders


CDMO Samsung Biologics telegraphs spinoff of biosim unit

 

Featured

GSK revs up launch plans after Nucala's FDA approval in COPD, targeting £500M opportunity

While GSK’s Nucala may not have earned the distinction of becoming the first FDA approved biologic for COPD, the British drugmaker is confident its IL-5 antibody still has a major role to play in tackling the traditionally tough-to-treat respiratory condition. And now, the company has a fresh FDA green light to put its thesis to the test.
 

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Sanofi inks $470M Vigil buyout, brushing off rivals' failures to join Novartis in Alzheimer's race

Sanofi’s 11 months watching over Vigil Neuroscience have led to a $470 million buyout. With the biotech into the last year of its cash runway, Sanofi has swept in to secure a small molecule that could challenge Novartis for the Alzheimer’s disease market.

FDA advisors unanimously snub Pfizer's Talzenna in broader prostate cancer population

Eight outside experts on the FDA’s Oncologic Drugs Advisory Committee delivered a unanimous ‘No’ vote on the question of whether Pfizer’s PARP inhibitor Talzenna has a favorable benefit-risk profile in metastatic castration-resistant prostate cancer patients without homologous recombination repair gene mutations.

With Illumina sequencers under an import ban, PacBio expands its footprint in China

Xi'an-based Haorui Gene will distribute PacBio's Vega benchtop system across the country while also offering product support.

Gilead pays partner Hookipa $10M to take over HBV, HIV therapeutic vaccine programs

Gilead is paying $10 million for sole ownership of arenaviral immunotherapies for hepatitis B (HBV) and HIV resulting from the company’s long-running collaboration with Hookipa Pharma.

Novo offers Wegovy discount for new patients, launches new ad campaign as time runs out for compounders

Patients new to branded Wegovy can access a one-month supply for $199 as part of Novo's efforts to reach more patients in a market that's been long affected by compounders.

CDMO Samsung Biologics telegraphs spinoff of biosim unit

Samsung Biologics will devote itself fully to contract manufacturing under a plan to spin off a new investment holding company that will oversee the drugmaker’s biosimilar subsidiary Samsung Bioepis. Samsung Bio attributed the decision to industry concerns about conflicts-of-interest between its CDMO and biosimilar development businesses.

Eikon blames US funding cuts for 15% staff reduction centered on research tools business

Only three months after banking an eye-popping $350 million series D round, Eikon Therapeutics is blaming government funding cuts for its decision to lay off 15% of its employees.

AstraZeneca, Merck duke it out at the top of oncologists’ pharma perception ranking

AstraZeneca and Merck are still leading the pack when it comes to how oncologists perceive makers of cancer drugs, according to a new report from ZoomRx.

France invests €1.3M into novel mRNA project led by OSE Immunotherapeutics

French biotech OSE Immunotherapeutics is taking charge of a new project aimed at fast-tracking nanodrug development and creating new mRNA therapeutics, with 1.3 million euros ($1.47 million) in support from the French government.

CSL Behring's first commercial shows Hizentra erasing germ concerns for primary immunodeficiency patients

Decades into its tenure as a drug seller, CSL Behring has finally dipped its toe into the waters of TV advertising.
 
Fierce podcasts

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'The Top Line': A Fierce breakdown of the 'most favored nation' executive order

This week on "The Top Line," Fierce Pharma breaks down President Donald Trump’s executive order targeting drug prices and what it could mean for the industry as broader policy shifts unfold.

 

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Best Practice Medical Affairs Organization Study Report

We interviewed 24 Medical Affairs leaders on the critical success factors for building a Best Practice Medical Affairs organization. This report shares what we learned.
 

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